Aripiprazole (Abilify®) as an Adjunctive Treatment for Inadequate Response in Major Depressive Disorder

NCT ID: NCT01696617

Last Updated: 2019-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-10
• Study Completion Date: 2019-02-28

Brief Summary

The investigators hypothesized that combined pharmacotherapy using adjunctive aripiprazole of standard antidepressants would be associated with improved depression response in Major depressive disorder, especially in Quality of life.

The investigators compare the mean changes in the quality of life between before add-on and 8 weeks treatment of aripiprazole and between before add-on and 6 weeks treatment of aripiprazole.

Detailed Description

Previous study about quality of life measurement in patients with depression have been reported that quality of life have to be measured irrespective with the severity of depression because quality of life has some other aspect to depression.The investigators have designed a 6-week single blinded study with flexible dose aripiprazole augmentation, ranging from 2.5mg to maximum 20 mg (15mg for patients on fluoxetine or paroxetine), in patients who responded inadequately (a score of >18 on the MADRS) to first-line antidepressant pharmacotherapy. The investigators compare the mean changes from in the quality of life at 8 weeks.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Aripiprazole 8-week group

Adjunctive aripiprazole 8-week treatment

Group Type: EXPERIMENTAL

Aripiprazole 6-week group

Intervention Type: DRUG

Aripiprazole 6-week group

Adjunctive aripiprazole 6-week treatment

Group Type: ACTIVE_COMPARATOR

Aripiprazole 8-week group

Intervention Type: DRUG

Interventions

Aripiprazole 6-week group

Intervention Type: DRUG

Aripiprazole 8-week group

Intervention Type: DRUG

Other Intervention Names

Abilify®; Abilify®

Eligibility Criteria

Inclusion Criteria

• Age : 18-65
• Patients with major depressive disorder according to DSM-IV criteria that have lasted >8 weeks
• MADRS total score of 18 or higher
• Patients who responded inadequately (a score of >18 on the MADRS) to first-line antidepressant treatment of 4 week duration
• Current use of standard antidepressant treatment in monotherapy or combination of 2 antidepressants : escitalopram (10 - 20mg/d), fluoxetine(20 - 40mg/d), paroxetine CR(25 - 50mg/d), sertraline(100 - 150mg/d), mirtazapine (15 - 45mg/d), duloxetine (30 - 60mg/d) or venlafaxine ER(150-225mg/d)

Exclusion Criteria

• Past history of hypersensitivity to aripiprazole
• Primary diagnosis of MDD with psychotic feature, bipolar disorder, schizophrenia, schizoaffective disorder, other psychotic disorder or anxiety disorder, a history of alcohol/ drug abuse within the past 12 months, or a diagnosis of dementia
• Clinically significant current Axis II (DSM-IV-TR) diagnosis
• A significant risk of suicide corroborated by a score of ≥5 on item 10(suicidal thoughts) on the MADRS scale or by clinical judgment of the investigator
• Pregnancy or in breast-feeding
• Presence of a serious medical illness including cardiac, hepatic, renal, respiratory, endocrinologic, neurologic, or hematologic disease or physical disorder judged to significantly affect central nervous system function
• Patients taking antipsychotics, mood stabilizer or any psychotropic medications besides antidepressants, except benzodiazepines or beta blockers or hypnotics
• Patients with past treatment failures of aripiprazole

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yong Min Ahn

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yong Min Ahn, MD. Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

031-KOC-1108i

Identifier Type: -

Identifier Source: org_study_id